Residual Replication of HIV-1 in the Gut Associated Lymphoid Tissue (GALT) of Patients on Highly Active Antiretroviral Therapy (HAART): the ANRS EP 44 Study
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Purpose
HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.
| Condition | Intervention |
|---|---|
|
HIV Infection |
Procedure: GI endoscopy and GALT biopsies Biological: A sample of venous blood will also be collected |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study |
- Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT. [ Designated as safety issue: No ]
- HIV-1 DNA load in the GALT vs blood CD4+ T cells [ Designated as safety issue: No ]
- HIV-1 tropism in the GALT vs blood CD4+ T cells [ Designated as safety issue: No ]
- Characterization of residual HIV-1 in the plasma < 40 copies/ml [ Designated as safety issue: No ]
- Characterization of HIV-1 DNA in blood monocytes [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| HIV-1-infected patients on effective HAART |
Procedure: GI endoscopy and GALT biopsies
This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)
Biological: A sample of venous blood will also be collected
These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT
|
| Non Infected HIV Volunteers |
Procedure: GI endoscopy and GALT biopsies
This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)
Biological: A sample of venous blood will also be collected
These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT
|
Detailed Description:
Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on HAART. This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood will also be collected. These samples will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1 coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This project could provide further insights into the residual replication of HIV-1 in subjects receiving HAART.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- HIV-1 infection (ELISA and western-blot tests)
- Continuous antiretroviral therapy >= 12 months
- Plasma HIV-1 RNA =< 40 copies/ml >= 6 months
- Indication of gastro-intestinal endoscopy
- Age >= 18-year old
- Physical examination
- Informed consent
Exclusion Criteria:
- Plasma HIV-1 RNA > 40 copies/ml in the last 6 months
- Involvement in a HIV vaccine study
- Treatment with interferon-alpha or PEG- interferon-alpha in the last 6 months
- Treatment with interleukin-2 in the last 6 months
- Decompensated cirrhosis
- Abnormal hemostasis tests
- Inflammatory bowel disease ; coeliac disease
- Lymphoma
- Blood transfusion in the last 6 months
- Absence of social security (health insurance)
- Pregnant or breastfeeding woman
- Incapable adult
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Lucie Marchand/Project manager, French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT01038401 History of Changes |
| Other Study ID Numbers: | 2008-A00239-46 |
| Study First Received: | December 22, 2009 |
| Last Updated: | July 13, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV infection HAART Viral DNA test positive-10063306 Blood HIV RNA 10049826 Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013